Early treatment of Parkinson's Disease with cabergoline delays the onset of motor complications: Results of a double-blind levodopa controlled trial
Identifieur interne : 001632 ( PascalFrancis/Corpus ); précédent : 001631; suivant : 001633Early treatment of Parkinson's Disease with cabergoline delays the onset of motor complications: Results of a double-blind levodopa controlled trial
Auteurs : U. K. Rinne ; F. Bracco ; C. Chouza ; E. Dupont ; O. Gershanik ; J. F. Marti Masso ; J. L. Montastruc ; C. D. MarsdenSource :
- Drugs : (Basel) [ 0012-6667 ] ; 1998.
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- Pascal (Inist)
English descriptors
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Abstract
This multicentre randomised double-blind 3- to 5-year trial was designed to assess whether initial therapy with cabergoline alone or in combination with levodopa prevents or delays the occurrence of long term motor complications in patients with early Parkinson's disease. Patients eligible for study inclusion (n = 412) had early idiopathic Parkinson's disease (Hoehn and Yahr stages 1 to 3) and had received no previous treatment with levodopa, selegiline or dopamine agonists. Patients were randomised to receive either cabergoline (0.25 to 4mg once daily) or levodopa (100 to 600 mg/day) titrated over a maximum period of 24 weeks. Once the optimum or maximum tolerated dose was achieved, it was maintained up to the end-point (development of motor complications confirmed at 2 consecutive 3-month visits) or up to a minimum of 3 years' treatment. Open labelled levodopa was added in both treatment arms when the improvement in motor disability [Unified Parkinson's Disease Rating Scale (UPDRS) factor III] decreased below 30% vs baseline. Both treatments improved motor disability, decreasing UPDRS factor III scores and factor II scores for activities of daily living. The development of motor complications (end-point) was significantly less frequent in patients treated with cabergoline than in levodopa recipients (22% vs 34% ; p < 0.02). The relative risk of developing motor complications during treatment with cabergoline was more than 50% lower than with levodopa. Serious adverse events, either drug related or not, were slightly more frequent in cabergoline-treated patients (31%) than in those treated with levodopa (25%). The withdrawal rate in the cabergoline v-I levodopa group was 16 vs 13%. In conclusion, the study shows that, in patients with early Parkinson's disease, cabergoline is effective either as monotherapy or combined with levodopa. Moreover, starting treatment with cabergoline significantly delays the development of motor complications.
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Format Inist (serveur)
NO : | PASCAL 98-0176336 INIST |
---|---|
ET : | Early treatment of Parkinson's Disease with cabergoline delays the onset of motor complications: Results of a double-blind levodopa controlled trial |
AU : | RINNE (U. K.); BRACCO (F.); CHOUZA (C.); DUPONT (E.); GERSHANIK (O.); MARTI MASSO (J. F.); MONTASTRUC (J. L.); MARSDEN (C. D.); MARSDEN (C. D.) |
AF : | Department of Neurology, University of Turku/Turku/Finlande (1 aut.); Clinica Neurologica, Università di Padova/Padova/Italie (2 aut.); Instituto de Neurologia, Hospital de Clinicas/Montevideo/Uruguay (3 aut.); Department of Neurology, Århus Kommunehospital/Århus/Danemark (4 aut.); Centro Neurologico, Hospital Frances/Buenos Aires/Argentine (5 aut.); Department of Neurology, Hospital Ntra. Sra. de Aranzazu/San Sebastian/Espagne (6 aut.); Centre Hospitalier Universitaire/Toulouse/France (7 aut.); The National Hospital for Neurology and Neurosurgery/London/Royaume-Uni (8 aut.); Institute of Neurology, and The National Hospital for Neurology and Neurosurgery/London/Royaume-Uni (1 aut.) |
DT : | Publication en série; Congrès; Niveau analytique |
SO : | Drugs : (Basel); ISSN 0012-6667; Coden DRUGAY; Nouvelle-Zélande; Da. 1998; Vol. 55; No. SUP1; Pp. 23-30; Bibl. 21 ref. |
LA : | Anglais |
EA : | This multicentre randomised double-blind 3- to 5-year trial was designed to assess whether initial therapy with cabergoline alone or in combination with levodopa prevents or delays the occurrence of long term motor complications in patients with early Parkinson's disease. Patients eligible for study inclusion (n = 412) had early idiopathic Parkinson's disease (Hoehn and Yahr stages 1 to 3) and had received no previous treatment with levodopa, selegiline or dopamine agonists. Patients were randomised to receive either cabergoline (0.25 to 4mg once daily) or levodopa (100 to 600 mg/day) titrated over a maximum period of 24 weeks. Once the optimum or maximum tolerated dose was achieved, it was maintained up to the end-point (development of motor complications confirmed at 2 consecutive 3-month visits) or up to a minimum of 3 years' treatment. Open labelled levodopa was added in both treatment arms when the improvement in motor disability [Unified Parkinson's Disease Rating Scale (UPDRS) factor III] decreased below 30% vs baseline. Both treatments improved motor disability, decreasing UPDRS factor III scores and factor II scores for activities of daily living. The development of motor complications (end-point) was significantly less frequent in patients treated with cabergoline than in levodopa recipients (22% vs 34% ; p < 0.02). The relative risk of developing motor complications during treatment with cabergoline was more than 50% lower than with levodopa. Serious adverse events, either drug related or not, were slightly more frequent in cabergoline-treated patients (31%) than in those treated with levodopa (25%). The withdrawal rate in the cabergoline v-I levodopa group was 16 vs 13%. In conclusion, the study shows that, in patients with early Parkinson's disease, cabergoline is effective either as monotherapy or combined with levodopa. Moreover, starting treatment with cabergoline significantly delays the development of motor complications. |
CC : | 002B02B06 |
FD : | Cabergoline; Chimiothérapie; Traitement; Précoce; Prévention; Toxicité; Parkinson maladie; Homme; Etude multicentrique; Randomisation; Etude double insu; Essai thérapeutique contrôlé; Ergot dérivé |
FG : | Système nerveux pathologie; Système nerveux central pathologie; Encéphale pathologie; Extrapyramidal syndrome; Maladie dégénérative |
ED : | Cabergoline; Chemotherapy; Treatment; Early; Prevention; Toxicity; Parkinson disease; Human; Multicenter study; Randomization; Double blind study; Controlled therapeutic trial; Ergot derivatives |
EG : | Nervous system diseases; Central nervous system disease; Cerebral disorder; Extrapyramidal syndrome; Degenerative disease |
GD : | Aufbereiten; Giftigkeit |
SD : | Cabergolina; Quimioterapia; Tratamiento; Precoz; Prevención; Toxicidad; Parkinson enfermedad; Hombre; Estudio multicéntrico; Aleatorización; Estudio doble ciego; Ensayo terapéutico controlado; Ergot derivado |
LO : | INIST-15326.354000078173570040 |
ID : | 98-0176336 |
Links to Exploration step
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<term>Ergot derivatives</term>
<term>Human</term>
<term>Multicenter study</term>
<term>Parkinson disease</term>
<term>Prevention</term>
<term>Randomization</term>
<term>Toxicity</term>
<term>Treatment</term>
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<keywords scheme="Pascal" xml:lang="fr"><term>Cabergoline</term>
<term>Chimiothérapie</term>
<term>Traitement</term>
<term>Précoce</term>
<term>Prévention</term>
<term>Toxicité</term>
<term>Parkinson maladie</term>
<term>Homme</term>
<term>Etude multicentrique</term>
<term>Randomisation</term>
<term>Etude double insu</term>
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<front><div type="abstract" xml:lang="en">This multicentre randomised double-blind 3- to 5-year trial was designed to assess whether initial therapy with cabergoline alone or in combination with levodopa prevents or delays the occurrence of long term motor complications in patients with early Parkinson's disease. Patients eligible for study inclusion (n = 412) had early idiopathic Parkinson's disease (Hoehn and Yahr stages 1 to 3) and had received no previous treatment with levodopa, selegiline or dopamine agonists. Patients were randomised to receive either cabergoline (0.25 to 4mg once daily) or levodopa (100 to 600 mg/day) titrated over a maximum period of 24 weeks. Once the optimum or maximum tolerated dose was achieved, it was maintained up to the end-point (development of motor complications confirmed at 2 consecutive 3-month visits) or up to a minimum of 3 years' treatment. Open labelled levodopa was added in both treatment arms when the improvement in motor disability [Unified Parkinson's Disease Rating Scale (UPDRS) factor III] decreased below 30% vs baseline. Both treatments improved motor disability, decreasing UPDRS factor III scores and factor II scores for activities of daily living. The development of motor complications (end-point) was significantly less frequent in patients treated with cabergoline than in levodopa recipients (22% vs 34% ; p < 0.02). The relative risk of developing motor complications during treatment with cabergoline was more than 50% lower than with levodopa. Serious adverse events, either drug related or not, were slightly more frequent in cabergoline-treated patients (31%) than in those treated with levodopa (25%). The withdrawal rate in the cabergoline v-I levodopa group was 16 vs 13%. In conclusion, the study shows that, in patients with early Parkinson's disease, cabergoline is effective either as monotherapy or combined with levodopa. Moreover, starting treatment with cabergoline significantly delays the development of motor complications.</div>
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<fC01 i1="01" l="ENG"><s0>This multicentre randomised double-blind 3- to 5-year trial was designed to assess whether initial therapy with cabergoline alone or in combination with levodopa prevents or delays the occurrence of long term motor complications in patients with early Parkinson's disease. Patients eligible for study inclusion (n = 412) had early idiopathic Parkinson's disease (Hoehn and Yahr stages 1 to 3) and had received no previous treatment with levodopa, selegiline or dopamine agonists. Patients were randomised to receive either cabergoline (0.25 to 4mg once daily) or levodopa (100 to 600 mg/day) titrated over a maximum period of 24 weeks. Once the optimum or maximum tolerated dose was achieved, it was maintained up to the end-point (development of motor complications confirmed at 2 consecutive 3-month visits) or up to a minimum of 3 years' treatment. Open labelled levodopa was added in both treatment arms when the improvement in motor disability [Unified Parkinson's Disease Rating Scale (UPDRS) factor III] decreased below 30% vs baseline. Both treatments improved motor disability, decreasing UPDRS factor III scores and factor II scores for activities of daily living. The development of motor complications (end-point) was significantly less frequent in patients treated with cabergoline than in levodopa recipients (22% vs 34% ; p < 0.02). The relative risk of developing motor complications during treatment with cabergoline was more than 50% lower than with levodopa. Serious adverse events, either drug related or not, were slightly more frequent in cabergoline-treated patients (31%) than in those treated with levodopa (25%). The withdrawal rate in the cabergoline v-I levodopa group was 16 vs 13%. In conclusion, the study shows that, in patients with early Parkinson's disease, cabergoline is effective either as monotherapy or combined with levodopa. Moreover, starting treatment with cabergoline significantly delays the development of motor complications.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002B02B06</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Cabergoline</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG"><s0>Cabergoline</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Cabergolina</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE"><s0>Chimiothérapie</s0>
<s5>04</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG"><s0>Chemotherapy</s0>
<s5>04</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA"><s0>Quimioterapia</s0>
<s5>04</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Traitement</s0>
<s5>07</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Treatment</s0>
<s5>07</s5>
</fC03>
<fC03 i1="03" i2="X" l="GER"><s0>Aufbereiten</s0>
<s5>07</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Tratamiento</s0>
<s5>07</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Précoce</s0>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Early</s0>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Precoz</s0>
<s5>10</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Prévention</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Prevention</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Prevención</s0>
<s5>11</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Toxicité</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Toxicity</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="GER"><s0>Giftigkeit</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Toxicidad</s0>
<s5>12</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Parkinson maladie</s0>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Parkinson disease</s0>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Parkinson enfermedad</s0>
<s5>13</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Homme</s0>
<s5>14</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Human</s0>
<s5>14</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Hombre</s0>
<s5>14</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Etude multicentrique</s0>
<s5>16</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Multicenter study</s0>
<s5>16</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Estudio multicéntrico</s0>
<s5>16</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE"><s0>Randomisation</s0>
<s5>17</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG"><s0>Randomization</s0>
<s5>17</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA"><s0>Aleatorización</s0>
<s5>17</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE"><s0>Etude double insu</s0>
<s5>18</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG"><s0>Double blind study</s0>
<s5>18</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA"><s0>Estudio doble ciego</s0>
<s5>18</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE"><s0>Essai thérapeutique contrôlé</s0>
<s5>19</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG"><s0>Controlled therapeutic trial</s0>
<s5>19</s5>
</fC03>
<fC03 i1="12" i2="X" l="SPA"><s0>Ensayo terapéutico controlado</s0>
<s5>19</s5>
</fC03>
<fC03 i1="13" i2="X" l="FRE"><s0>Ergot dérivé</s0>
<s5>25</s5>
</fC03>
<fC03 i1="13" i2="X" l="ENG"><s0>Ergot derivatives</s0>
<s5>25</s5>
</fC03>
<fC03 i1="13" i2="X" l="SPA"><s0>Ergot derivado</s0>
<s5>25</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Système nerveux pathologie</s0>
<s5>69</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Nervous system diseases</s0>
<s5>69</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Sistema nervioso patología</s0>
<s5>69</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Système nerveux central pathologie</s0>
<s5>70</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Central nervous system disease</s0>
<s5>70</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Sistema nervosio central patología</s0>
<s5>70</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Encéphale pathologie</s0>
<s5>71</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Cerebral disorder</s0>
<s5>71</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Encéfalo patología</s0>
<s5>71</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Extrapyramidal syndrome</s0>
<s5>72</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Extrapyramidal syndrome</s0>
<s5>72</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Extrapiramidal síndrome</s0>
<s5>72</s5>
</fC07>
<fC07 i1="05" i2="X" l="FRE"><s0>Maladie dégénérative</s0>
<s5>73</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG"><s0>Degenerative disease</s0>
<s5>73</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA"><s0>Enfermedad degenerativa</s0>
<s5>73</s5>
</fC07>
<fN21><s1>117</s1>
</fN21>
</pA>
<pR><fA30 i1="01" i2="1" l="ENG"><s1>Cabergoline: Advantages of Sustained Dopaminergic Stimulation. Satellite Symposium</s1>
<s3>London GBR</s3>
<s4>1997-03</s4>
</fA30>
</pR>
</standard>
<server><NO>PASCAL 98-0176336 INIST</NO>
<ET>Early treatment of Parkinson's Disease with cabergoline delays the onset of motor complications: Results of a double-blind levodopa controlled trial</ET>
<AU>RINNE (U. K.); BRACCO (F.); CHOUZA (C.); DUPONT (E.); GERSHANIK (O.); MARTI MASSO (J. F.); MONTASTRUC (J. L.); MARSDEN (C. D.); MARSDEN (C. D.)</AU>
<AF>Department of Neurology, University of Turku/Turku/Finlande (1 aut.); Clinica Neurologica, Università di Padova/Padova/Italie (2 aut.); Instituto de Neurologia, Hospital de Clinicas/Montevideo/Uruguay (3 aut.); Department of Neurology, Århus Kommunehospital/Århus/Danemark (4 aut.); Centro Neurologico, Hospital Frances/Buenos Aires/Argentine (5 aut.); Department of Neurology, Hospital Ntra. Sra. de Aranzazu/San Sebastian/Espagne (6 aut.); Centre Hospitalier Universitaire/Toulouse/France (7 aut.); The National Hospital for Neurology and Neurosurgery/London/Royaume-Uni (8 aut.); Institute of Neurology, and The National Hospital for Neurology and Neurosurgery/London/Royaume-Uni (1 aut.)</AF>
<DT>Publication en série; Congrès; Niveau analytique</DT>
<SO>Drugs : (Basel); ISSN 0012-6667; Coden DRUGAY; Nouvelle-Zélande; Da. 1998; Vol. 55; No. SUP1; Pp. 23-30; Bibl. 21 ref.</SO>
<LA>Anglais</LA>
<EA>This multicentre randomised double-blind 3- to 5-year trial was designed to assess whether initial therapy with cabergoline alone or in combination with levodopa prevents or delays the occurrence of long term motor complications in patients with early Parkinson's disease. Patients eligible for study inclusion (n = 412) had early idiopathic Parkinson's disease (Hoehn and Yahr stages 1 to 3) and had received no previous treatment with levodopa, selegiline or dopamine agonists. Patients were randomised to receive either cabergoline (0.25 to 4mg once daily) or levodopa (100 to 600 mg/day) titrated over a maximum period of 24 weeks. Once the optimum or maximum tolerated dose was achieved, it was maintained up to the end-point (development of motor complications confirmed at 2 consecutive 3-month visits) or up to a minimum of 3 years' treatment. Open labelled levodopa was added in both treatment arms when the improvement in motor disability [Unified Parkinson's Disease Rating Scale (UPDRS) factor III] decreased below 30% vs baseline. Both treatments improved motor disability, decreasing UPDRS factor III scores and factor II scores for activities of daily living. The development of motor complications (end-point) was significantly less frequent in patients treated with cabergoline than in levodopa recipients (22% vs 34% ; p < 0.02). The relative risk of developing motor complications during treatment with cabergoline was more than 50% lower than with levodopa. Serious adverse events, either drug related or not, were slightly more frequent in cabergoline-treated patients (31%) than in those treated with levodopa (25%). The withdrawal rate in the cabergoline v-I levodopa group was 16 vs 13%. In conclusion, the study shows that, in patients with early Parkinson's disease, cabergoline is effective either as monotherapy or combined with levodopa. Moreover, starting treatment with cabergoline significantly delays the development of motor complications.</EA>
<CC>002B02B06</CC>
<FD>Cabergoline; Chimiothérapie; Traitement; Précoce; Prévention; Toxicité; Parkinson maladie; Homme; Etude multicentrique; Randomisation; Etude double insu; Essai thérapeutique contrôlé; Ergot dérivé</FD>
<FG>Système nerveux pathologie; Système nerveux central pathologie; Encéphale pathologie; Extrapyramidal syndrome; Maladie dégénérative</FG>
<ED>Cabergoline; Chemotherapy; Treatment; Early; Prevention; Toxicity; Parkinson disease; Human; Multicenter study; Randomization; Double blind study; Controlled therapeutic trial; Ergot derivatives</ED>
<EG>Nervous system diseases; Central nervous system disease; Cerebral disorder; Extrapyramidal syndrome; Degenerative disease</EG>
<GD>Aufbereiten; Giftigkeit</GD>
<SD>Cabergolina; Quimioterapia; Tratamiento; Precoz; Prevención; Toxicidad; Parkinson enfermedad; Hombre; Estudio multicéntrico; Aleatorización; Estudio doble ciego; Ensayo terapéutico controlado; Ergot derivado</SD>
<LO>INIST-15326.354000078173570040</LO>
<ID>98-0176336</ID>
</server>
</inist>
</record>
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